8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) April 3, 2011

VIVUS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-33389	94-3136179
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1172 CASTRO STREET

MOUNTAIN VIEW, CA 94040

(Address of principal executive offices, including zip code)

(650) 934-5200

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01.  Regulation FD Disclosure

On April 3, 2011, VIVUS, Inc, or the Company, presented a poster entitled “Weight Loss and Cardiovascular Risk Reduction Over 2 Years With Controlled-Release Phentermine-Topiramate” beginning at 1:30 p.m. CT at the 60th Annual Scientific Meeting of The American College of Cardiology, being held April 2-5 in New Orleans, Louisiana.  A graphical representation of the poster (including the reproduction of the contents) presented by the Company is attached hereto as Exhibit 99.1.

Item 8.01.  Other Events

On April 4, 2011, VIVUS, Inc. issued a press release titled “Weight Loss With QNEXA® Over Two Years Provides Patients With Substantial Cardiovascular Benefits.”  A copy of the press release is attached hereto as Exhibit 99.2.

The information in this Form 8-K and the exhibits attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference into any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01.  Financial Statements and Exhibits

(d)Exhibits.

Exhibit No.	Description
99.1	Poster dated April 3, 2011, entitled, “Weight Loss and Cardiovascular Risk Reduction Over 2 Years With Controlled-Release Phentermine-Topiramate” and a reproduction of the contents thereof.
99.2	Press Release dated April 4, 2011.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	VIVUS, INC.
By:	/s/ Lee B. Perry
	Lee B. Perry
	Vice President and Chief Accounting Officer

Date: April 4, 2011

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Poster dated April 3, 2011, entitled, “Weight Loss and Cardiovascular Risk Reduction Over 2 Years With Controlled-Release Phentermine-Topiramate” and a reproduction of the contents thereof.
99.2	Press Release dated April 4, 2011.

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EX-99.1

Exhibit 99.1

Below is a graphical representation of the poster entitled “Weight Loss and Cardiovascular Risk Reduction Over 2 Years With Controlled-Release Phentermine-Topiramate”:

Below is a reproduction of the contents of the poster entitled “Weight Loss and Cardiovascular Risk Reduction Over 2 Years With Controlled-Release Phentermine-Topiramate”:

Authors: Michael Davidson, MD, FACC, FACP, FNLA(a); Charles H. Bowden, MD(b); Wesley W. Day, PhD(b)

(a) The University of Chicago Pritzker School of Medicine, Chicago, Illinois, USA; (b) VIVUS, Inc., Mountain View, California, USA

·Introduction

·Obesity is reaching epidemic proportions in the United States(1) and is associated with several comorbidities, such as dyslipidemia and hypertension, which contribute to an increased risk of cardiovascular disease (CVD).(1)-(4)

·Weight loss has been shown to have a positive effect on CVD risk factors:

·Modest weight loss can normalize blood pressure (BP) and has been shown to reduce or even negate the need for antihypertensive medication.(3)

·Weight loss is also a recommended strategy for reducing total cholesterol, low-density lipoprotein cholesterol (LDL-C), and triglycerides and increasing high-density lipoprotein cholesterol (HDL-C).(4)

·An investigational controlled-release combination of low-dose phentermine and topiramate (PHEN/TPM CR) was developed as a chronic therapy to effect clinically meaningful weight loss with the potential to improve CVD risk factors.

· Objective

·To determine the cardiovascular benefits associated with weight loss resulting from 2 years of treatment with PHEN/TPM CR in subjects with weight-related comorbidities.

· Methods

·PHEN/TPM CR was evaluated over 108 weeks in 2 consecutive clinical studies:

·CONQUER was a 56-week, double-blind, placebo-controlled, Phase 3 trial of 2487 overweight/obese adult subjects with >2 weight-related comorbidities who were randomized to placebo, PHEN 7.5 mg/TPM CR 46 mg (7.5/46), or PHEN 15 mg/TPM CR 92 mg (15/92).

·Subjects from selected sites who completed CONQUER on treatment were eligible to enter SEQUEL, a double-blind, placebo-controlled extension of the CONQUER study consisting of a further 52-week treatment period in which subjects continued on their original double-blind treatment.

·All subjects were managed to standard of care for their respective comorbidities and received lifestyle modification, including guidance on nutrition and increased physical activity, based on the LEARN® program.(5)

· Assessments

·Primary efficacy variables were mean percent weight loss at 56 weeks (CONQUER subjects) and 108 weeks (SEQUEL subjects) and the percentage of SEQUEL subjects achieving >5% weight loss at 108 weeks in the intent-to-treat (ITT) population with last observation carried forward (ITT-LOCF).

·Secondary efficacy variables (SEQUEL) included percentage of subjects achieving >10%, >15%, or >20% weight loss and changes in BP, antihypertensive medication use, and lipid parameters in dyslipidemic subjects.

·Treatment groups were stratified according to the presence of comorbidities at baseline:

·Hypertension was defined as systolic BP >140 mm Hg and <160 mm Hg (>130 mm Hg and <160 mm Hg if diabetic) or diastolic BP >90 mm Hg and <100 mm Hg (>85 mm Hg and <100 mm Hg if diabetic)

·Dyslipidemia was defined as triglycerides >200 mg/dL and <400 mg/dL or those subjects on >2 lipid-lowering medications

·Analysis of covariance (ANCOVA) was used to evaluate changes in weight loss and other outcomes. The ANCOVA model used factors of treatment, gender, and diabetic status as fixed effects with baseline weight as a covariate.

· Results

Baseline characteristics

·At baseline (Week 0 of CONQUER study), the mean age of subjects was 51.9 years, mean weight was 101.7 kg, mean body mass index was 36.1 kg/m2, and mean waist circumference was 112.6 cm (safety set, N=675).

·The majority of subjects were female (66.4%) and Caucasian (85.3%); 51.1% had hypertension and 34.5% had dyslipidemia.

·The SEQUEL study completion rate on study drug was similar among treatment groups and placebo (86.3% for placebo, 82.5% for the 7.5/46 group, and 83.1% for the 15/92 group).

Weight loss and cardiovascular risk reduction

·Both PHEN/TPM CR doses resulted in significantly greater weight loss after 56 and 108 weeks compared with placebo (Figure 1).

·Significantly more PHEN/TPM CR-treated subjects also achieved >5%, >10%, >15%, or >20% weight loss vs placebo (P<0.0001 for all comparisons except weight loss >20% in the 7.5/46 group [P=0.0072]).

·In the overall ITT-LOCF sample, BP decreased in all groups (Figure 2A), as did the need for antihypertensive medications among PHEN/TPM CR–treated subjects (Figure 2B).

·Similar results were seen in hypertensive subjects in all groups (Figure 3).

·In dyslipidemic subjects, lipid parameters showed improvements with treatment from baseline to 108 weeks (Figure 4).

Safety summary

·Treatment with PHEN/TPM CR was generally well tolerated with no new safety signals seen between 56 and 108 weeks (most common treatment-emergent adverse events [TEAEs] in Table 1).

·The percentage of subjects who discontinued study drug due to AEs was 3.1% in the placebo group, 4.6% in the 7.5/46 group, and 4.4% in the 15/92 group.

·In total, 47 subjects had a serious AE (SAE) between baseline and Week 108: 14 (6.2%) subjects in the placebo group, 9 (5.9%) in the 7.5/46 group, and 24 (8.1%) in the 15/92 group.

·There were no treatment-related SAEs.

Table 1. Most Common TEAEs Occurring Between Baseline and Week 108

Adverse event	Placebo (n=227) n (%)	PHEN/TPM CR 7.5/46 (n=153) n (%)	PHEN/TPM CR 15/92 (n=295) n (%)
Upper respiratory tract infection	32.6	27.5	28.5
Constipation	9.7	22.2	22.7
Paraesthesia	2.6	14.4	22.4
Sinusitis	13.7	15.7	21.0
Dry mouth	2.6	14.4	20.7
Nasopharyngitis	22.0	19.0	17.3
Dysgeusia	1.8	11.8	13.6
Headache	11.5	7.2	12.9
Insomnia	9.7	12.4	11.5
Back pain	11.5	11.1	11.5

· Conclusions

·The current obesity epidemic increases the urgency for therapies that can provide sustained weight loss and clinically meaningful improvements in weight-related comorbidities.

·PHEN/TPM CR is associated with significant weight loss that is sustained for 2 years in overweight/obese subjects.

·These reductions in body weight were associated with reductions in CVD risk factors in a population with significant comorbidities.

·Reductions in both systolic and diastolic BP were seen in both the overall sample and among subjects who were hypertensive at baseline.

·Significant improvements in HDL-C and triglycerides were seen in subjects who were dyslipidemic at baseline.

·These benefits to CVD risk factors were observed despite the decreased requirement for concomitant antihypertensive medications in the PHEN/TPM treatment groups.

·The net reduction in concomitant antihypertensive medications observed in the PHEN/TPM CR-treated groups yielded a net reduction in pill burden, whereas the placebo group experienced a net increase in concomitant medication burden.

·PHEN/TPM CR was generally well tolerated based on rates of study completion, discontinuation rates, and overall AEs.

These trials are registered at ClinicalTrials.gov, number NCT00553787 (CONQUER) and number NCT00796367 (SEQUEL).

References: 1. Pi-Sunyer X. Postgrad Med 2009; 121(6);21-33. 2. Tzotzas T. et al. Obes Rev 2010 Nov 3. doi: 10.1111/j.1467-789X.2010.00807.x. [Epub ahead of print]. 3. Mertens IL, et al. Obes Res 2000;8;270-278. 4. NHLBI. http//www.nhlbi.nih.gov/guidelines/obesity/prctgd_c.pdf. Accessed February 21, 2011. 5. Brownell KD. The LEARN Program for Weight Management. 2004.

Acknowledgements: We would like to acknowledge and thank the SEQUEL investigators and study coordinators, the Medpace team (study CRO), The Lockwood Group (for poster development assistance), and VIVUS internal contributors.

Author Disclosures: Dr. Davidson has served as a speaker/member of a speakers bureau for Abbott, AstraZeneca, GlaxoSmitKline (GSK), and Merck & CO; served as an advisor/consultant for Abbott, Aegerion, Amgen, AstraZeneca, Atherotech, CCBR-SYNARC, Daiichi-Sankyo, DTC MD, Esperion, GSK, Intelligent Medical Decisions, Kinemed, LipoScience, Merck & Co, Novo Nordisk, Omthera, Professional Evaluation, Roche, sanofi-aventis, Sonogene, Synarc, Takeda, and Vindico Medical Education; and has received grant/research support from Abbott, AstraZeneca, Daiichi-Sankyo, GSK, Merck & Co, and Roche. He holds no stock ownership in Radiant Research, a division of Swiss BioScience, or in any of the above companies. Dr. Davidson has served on the Board of Directors and holds equity in DTC MD, Omthera, Professional Evaluation, and Sonogene. Dr. Bowden and Dr. Day work for the manufacturer of the study drug.

EX-99.2

Exhibit 99.2

CONTACT:
VIVUS, Inc.	Investor Relations:	The Trout Group
Timothy E. Morris		Brian Korb
Chief Financial Officer		bkorb@troutgroup.com
650-934-5200		646-378-2923
	Media Relations:	GolinHarris
		Susan Brophy
		sbrophy@golinharris.com
		312-729-4359

WEIGHT LOSS WITH QNEXA® OVER TWO YEARS PROVIDES PATIENTS WITH
SUBSTANTIAL CARDIOVASCULAR BENEFITS

Long-Term Data from the SEQUEL Study Presented at the American College of Cardiology Shows Reduced Need for Blood Pressure Medications and Improvements in Lipids

MOUNTAIN VIEW, Calif., April 4, 2011 — VIVUS, Inc. (NASDAQ: VVUS) today announced long-term data that demonstrated patients treated with the investigational drug QNEXA® for two years showed reductions in blood pressure and the use of antihypertensive medications as well as improvements in lipid levels following significant reductions in weight loss as compared to those in the placebo group over two years.

The data — additional results from the SEQUEL study — were presented Sunday at the 60th Annual Scientific Meeting of The American College of Cardiology by Michael Davidson, M.D., clinical professor and director of preventive cardiology at The University of Chicago.

Specific results are as follows:

·Patients on QNEXA had significant reductions in weight loss as compared to those in the placebo group over two years.  Least-squares mean percent weight loss at week 108 was -9.3% and -10.5%, respectively, for the mid and top dose as compared to -1.8% for the placebo group.

·Overall, patients taking QNEXA showed a significant reduction in the number of antihypertensive medications they required as compared to those taking a placebo over two years of treatment.

·Specifically, patients with hypertension at the beginning of the study taking QNEXA mid and top dose showed a significant reduction in the number of antihypertensive medications they required of -9.8% and -18.9%, respectively, while patients taking a placebo showed a net increase of +4.2%.

VIVUS, Inc. 1172 Castro Street, Mountain View, CA 94040    Tel 650-934-5200   Fax 650-934-5389  www.vivus.com

·Dyslipidemic patients at baseline treated with the mid and top dose of QNEXA had decreases in triglycerides of -25.9% and -26.3%, respectively, as compared to -14.3% for the placebo group.

·Dyslipidemic patients at baseline treated with the mid and top dose of QNEXA had improvements in HDL-C of +11.4% and +16.7%, respectively, as compared to +9.1% for the placebo group.

“In this study, QNEXA patients on the top dose had sustained weight loss greater than 10% over two years. This weight loss led to clinically relevant reductions in blood pressure, triglyceride reduction greater than 25%, and a dramatic increase in HDL levels,” stated Dr. Davidson.  “Achieving and maintaining this degree of weight loss, one that impacts cardiovascular risk in a clinically meaningful way, is often difficult for patients. Maintaining double-digit weight loss over two years, with resulting improvements in cardiovascular risk factors and an overall reduction in medications used to treat comorbidities makes this important data for clinicians.”

QNEXA therapy was well tolerated, with no new safety signals seen between 56 and 108 weeks. The most common side effects were upper respiratory infection, constipation, tingling, sinus infection, dry mouth and runny nose. Serious adverse event rates over two years were low (mid and top dose 5.9%, 8.1%) and placebo (6.2%), with no drug-related serious adverse events reported. The completion rate in SEQUEL was approximately 83% for both QNEXA doses and 86% for the placebo group. Discontinuations due to adverse events were 4.6% and 4.4% for the mid and top dose, respectively, and 3.1% for the placebo group.

About the SEQUEL Study

SEQUEL (OB-305) was a double-blind, placebo-controlled, three-arm, prospective study. Patients continued receiving the same treatment assignment to which they had been randomized in the CONQUER study in a blinded fashion: either once-daily treatment with top-dose QNEXA (n=295), mid-dose QNEXA (n=153), or placebo (n=227). The SEQUEL study was a 52-week extension study for a subset of patients who completed the 56-week CONQUER study. The total study period was 108 weeks. SEQUEL included 675 obese or overweight patients, all of whom had two or more weight-related co-morbidities and an average baseline BMI of 36.1. Throughout the 108-week treatment period, all patients were advised to follow a modest lifestyle modification program including reduction of food intake by 500 calories per day.

About QNEXA Controlled Release Capsules

QNEXA [kyoo-nek-suh] is an investigational drug candidate being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. QNEXA is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior. In phase 2 and 3 clinical data to date, patients taking QNEXA have demonstrated statistically significant weight loss, glycemic control, and improvement in cardiovascular risk factors, when used in combination with a diet and lifestyle modification program.

About VIVUS

VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead product in clinical development, QNEXA®, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. QNEXA® is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction. For more information about the company, please visit www.vivus.com

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